UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Transtrochanteric rotational osteotomy and re-sphere of collapse for osteonecrosis of the femoral head, based on artificial bone filling
Title of the study (Brief title)	Transtrochanteric rotational osteotomy and re-sphere of collapse for osteonecrosis of the femoral head
Region	Japan

Condition
Condition	osteonecrosis of the femoral head
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is evaluate a clinical outcome after transtrochanteric rotational osteotomy and re-sphere of collapse for the femoral head in patients with osteonecrosis based on artificial bone filling
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Osteoarthritis after procedure using radiography
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Under transtrochanteric rotational osteotomy , artificial bone filling is performed for collapse of the femoral head in patients with osteonecrosis
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	55 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients who will undergo transtrochanteric rotational osteotomy with collapse of osteonecrosis of the femoral head
Key exclusion criteria	The patients that an effect is not obtained by transtrochanteric rotational osteotomy and artificial bone filling
Target sample size	100

Research contact person
Name of lead principal investigator	Takuaki Yamamoto
Organization	Fukuoka University Faculty of Medicine
Division name	Department of Orthopaedic Surgery
Address	7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL	092-801-1011
Email	yamamotot@fukuoka-u.ac.jp

Public contact
Name of contact person	Tetsuro Ishimatsu
Organization	Fukuoka University Faculty of Medicine
Division name	Department of Orthopaedic Surgery
Address	7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL	092-801-1011
Homepage URL
Email	md140002@yahoo.co.jp

Sponsor
Institute	Fukuoka University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 20 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 03 Month 20 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 03 Month 20 Day
Last modified on	2018 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036339